Dyad Plus Effectiveness/Feasibility

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-65
SponsorWake Forest University Health Sciences

About this trial

The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eligible for enrollment in Brenner FIT and/or By Design Essentials

Caregiver who lives in the house with a BMI > 30

No contraindication for physical activity or caloric restriction

Must be able to read and write English

Disqualifiers

BMI < 30

Contraindication for physical activity or caloric restriction

Cannot read or write English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brenner FIT Standard

    Behavioral

    After referral, families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and physical activity specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, physical activity, and parenting. Specialized visits with the physical activity specialist or dietician are scheduled as pertinent issues arise. Clinic visits include individualized goal setting (for behaviors family/clinician have agreed to address), healthy eating and physical activity education, and behavioral counseling to implement changes at home.

  • By Design Essentials

    Behavioral

    A dietitian provides each participant with a detailed program manual that describes the prescribed diet. The dietitian utilizes standard behavioral techniques to promote lifestyle behavior changes that enable participants to implement and maintain behaviors necessary to adhere to the dietary prescription. Participants also receive a standard exercise program designed to promote exercise energy expenditure of approximately 600 kilocalories\*/week. The exercise prescription includes resistance training for 2 days per week and aerobic training for 3 days per week, to meet a 600 kilocalories\*/week expenditure goal. Behaviorists meet with participants to provide individual and group-based counseling to learn the skills necessary to adopt the prescribed dietary pattern and exercise plans. Group sessions will be delivered consecutively over 6 months (20 total; 1.5 hours each).

  • Dyad Plus

    Behavioral

    This will include all components of the standard Brenner FIT program and By Design Essentials. In addition, group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. Dyads will attend 6 meetings that will last approximately 1 hour each.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Adolescent ParticipantsActive comparator 1 intervention
Group B: Caregivers of Adolescent ParticipantsExperimental treatment 1 intervention
Group C: Co-enrollmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

BMI z-score

Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

Time frame
Baseline
2

BMI z-score

Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

Time frame
6 months
3

Feasibility and Acceptability of Implementation

We will examine screening, recruitment, retention, adherence, and overall perception of Brenner FIT and By Design components

Time frame
Month 6

Secondary outcomes

1

Physical Activity Assessment Tool (PAAT)-Adult

Physical activity data will be collected using the Physical Activity Assessment Tool (PAAT). The PAAT measures type, frequency, and duration of moderate and vigorous physical activity from all four domains of physical activity-leisure, occupational, household, and transportation-in the last 7 days, and asks if this is "more, less, or about the same as usual" activity

Time frame
Baseline
2

Physical Activity Assessment Tool (PAAT)-Adult

Physical activity data will be collected using the Physical Activity Assessment Tool (PAAT). The PAAT measures type, frequency, and duration of moderate and vigorous physical activity from all four domains of physical activity-leisure, occupational, household, and transportation-in the last 7 days, and asks if this is "more, less, or about the same as usual" activity

Time frame
6 Months
3

Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)

Physical activity data will be collected using the Youth Physical Activity Questionnaire (YPAQ which contains 47 different activities broken into contextual settings/domains: sporting, leisure, school, and free-time activities and aims to measures frequency, duration, intensity, and mode, over the past 7 days of both PA and sedentary activities. The questionnaire will be self-administered via a REDCap survey. Study staff will be available to answer any questions that participants have during the process.

Time frame
Baseline
4

Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)

Physical activity data will be collected using the Youth Physical Activity Questionnaire (YPAQ which contains 47 different activities broken into contextual settings/domains: sporting, leisure, school, and free-time activities and aims to measures frequency, duration, intensity, and mode, over the past 7 days of both PA and sedentary activities. The questionnaire will be self-administered via a REDCap survey. Study staff will be available to answer any questions that participants have during the process.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Institutes of Health (NIH)

Collaborator